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Thursday, October 09, 2008

FDA Evaded Bidding Process to Hire Public Relations Firm Which Also Works for PhRMA

Last week, the Washington Post reported the unusual - shall we say - way that the US Food and Drug Administration went about setting up a public relations campaign to respond to some negative criticism it has been getting. Here is the background.

The U.S. Food and Drug Administration had an image problem. For months last year the agency had been pummeled by Congress for poor inspections of tainted vegetables, drugs and other products.

FDA leaders decided to hire a contractor for a public relations campaign that would 'create and foster a lasting positive public image of the agency for the American public,' according to agency documents.

How they went about doing this was out of the ordinary.

Tasked with the public relations job was Mildred Cooper, a temporary FDA consultant hired on a two-year contract to advise FDA Commissioner Andrew C. von Eschenbach and other officials. Hired in March, Cooper became an FDA civil servant.

Cooper, who had worked on Capitol Hill and in public affairs for the Federal Emergency Management Agency and Defense Department, called a friend at Qorvis [Communications Inc], which specializes in corporate communications.

Before she joined the FDA, Cooper had worked with Qorvis as a public affairs executive at Luna Innovations, a company that sells medical devices and other products and whose clients include the Defense Department.

'I had experience with Qorvis,' she said in an interview. 'We thought they could help with our communications effort. . . . It was a matter of efficiency.'

She was referred to Don Goldberg, who helps lead Qorvis's crisis communications practice and had once served as part of President Clinton's crisis management team.

The people involved seemed to have formulated a way to get around the usual government bidding process.

Goldberg discussed the project with [James] Dunn, a business consultant working with Qorvis, e-mails show. They decided to arrange for Qorvis to come into the project through ANI, the Alaska newspaper company, which runs several weeklies and a small public relations office.

Dunn, who works for a firm called Red Team Consulting, told The Post he had experience with the set-aside rules for Alaska Native corporations because he had worked for one as chief operating officer.

ANI, it turns out, is

a firm owned by an Alaska Native corporation that does not have to compete for federal work because it qualifies for special set-asides.

Then,

Other e-mails show that Cooper apparently allowed Qorvis to tailor terms of the contract known as the scope of work.

During most of these discussions, ANI itself was out of the loop.

no one from ANI appeared to be a part of the contract discussions, according to the e-mails. On Feb. 13, Goldberg forwarded a note to Cooper from 'the ANI team contact.' That day, the contact, Washington public relations veteran Aaron Guiterman, wrote to Goldberg, Qorvis and ANI that 'the most likely next step with the FDA is for ANI to submit a proposal.'

In a brief interview, Guiterman said he was not permitted to speak about the contract.

The final result was

On July 23, after more deliberation, the FDA issued a $300,000 purchase order for the public awareness campaign, with ANI listed as the contractor. An FDA official said ANI had pledged in writing to do more than half the work.

Two parts of this are remarkable, of course. One is how a government contract to a big Washington PR firm was arranged without any public bidding or scrutiny. The second was that the company chosen for this contract to improve the image of the FDA, the agency responsible for regulating pharmaceutical companies, went to a firm which also worked for PhRMA, the pharmaceutical industry trade organization. Could this excess coziness of some FDA officials with the pharmaceutical industry, which the agency is supposed to regulate, be evidence of "regulatory capture?" On a policy level, it seems that the US needs to have a much clearer separation between the FDA and the targets of its regulation.

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